cobas ampliprep manual

Please be aware that we do not take any responsibility for accessing such information, which may not comply with any valid legal process, regulation, registration or usage in New Zealand. If you require further information concerning a product listed on this site, please contact your local Roche Diagnostics New Zealand representative.”. Manual steps are limited to placing the samples and reagents to the instrument. This avoids any error which may occur in case of manual preparation. Efficiency and reliability of the results is further enhanced through the system for the detection of sample (Clot Detection). The correlation and concordance of results between the two assays were calculated. Further attention must be paid to those cases in which measured viral loads present larger differences between the two assays. Citing articles Article Metrics View article metrics About ScienceDirect Remote access Shopping cart Advertise Contact and support Terms and conditions Privacy policy We use cookies to help provide and enhance our service and tailor content and ads. By continuing you agree to the use of cookies. In a 24-h laboratory, this system can analyze 399 samples on one automated docked platform. Precision (within-run analysis) and linearity using regression analysis for the CAP-CTM HIV-1 v2.0 were measured on a specially prepared pooled plasma sample which was further divided into six aliquots. Seventy-five samples generated a “target not detected” result on any of the three real-time assays (a reflection of successful antiretroviral treatment at the clinic). The clinical impact of this improved sensitivity for patients being monitored on antiretroviral treatment programs remains to be determined. The variability of this difference (SD), however, is acceptable and shows good precision (reflected by a smaller distance between the limits of agreement) and overall good performance compared to the Abbott RealTi m e HIV-1. The application of this new CAP-CTM HIV-1 v.

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It has been the driving principle of our pioneering work in viral load monitoring since 1996. You can have confidence to stand behind — and take pride in — your work. When that happens, we have made a difference. Flexibility means the system can expand and adapt to your workflow and operational changes. From docked instrumentation to linked format, small to large volume workflow, batch or continuous loading mode, the system makes viral load monitoring practical for every lab. Designed to reduce hands-on time and further improve laboratory efficiency, the state-of-the-art cobas p 630 instrument improves your laboratory’s productivity while also providing the security that only comes from robotic assurance. Please be aware that we do not take any responsibility for accessing those information which may not comply with any legal process, regulation, registration or usage in the country of your origin. Please also be aware that the information in this website should not be used to diagnose, treat, cure or prevent any disease without the advice of a qualified medical professional, and does not replace medical advice or a medical examination.Please be aware that we do not take any responsibility for accessing those information which may not comply with any legal process, regulation, registration or usage in the country of your origin. Please also be aware that the information in this website should not be used to diagnose, treat, cure or prevent any disease without the advice of a qualified medical professional, and does not replace medical advice or a medical examination. Information on such websites is intended for a wide range of audiences. Some products described may not be licensed in accordance with New Zealand Medical Devices Regulations and therefore may not be available for sale in New Zealand.

Numerous new direct-acting antiviral (DAA) drugs and host-targeted agents (HTA) that block the HCV life cycle have reached early to late clinical development. With these new therapies, HCV RNA level monitoring is and will remain the most useful parameter to assess treatment responses and guide treatment decisions. HCV genotype 4 is currently increasing in incidence and prevalence in the intravenous drug user community in Western Europe and many industrialized areas ( 16, 17 ). It now represents approximately 10% of cases in France ( 17 ). HCV genotype 4 infection is difficult to treat and thus an important target of new HCV drug development. Therefore, accurate detection and quantification of HCV genotype 4 RNA is mandated in clinical trials with new HCV therapies and in clinical practice. MATERIALS AND METHODS Clinical specimens. Plasma and serum samples were obtained from patients infected with HCV genotype 4 referred to our Hepatology Reference Center with a diagnosis of chronic HCV infection and tested in our laboratory or diagnosed with HCV infection at the Cerba laboratory. Residual samples were used, and the patients gave their consent to their use. Group A comprised 122 patients with chronic HCV genotype 4 infection, all with detectable anti-HCV antibodies and HCV RNA. All samples were collected in 2011 and 2012. The genotype and subtype were determined by means of the reference method, i.e., sequencing of nonstructural 5B region of the HCV genome, followed by phylogenetic analysis, as previously described ( 18 ). Group A comprised 43 patients with subtype 4a, 4 with subtype 4c, 34 with subtype 4d, 9 with subtype 4e, 9 with subtype 4f, 2 with subtype 4g, 5 with subtype 4h, 4 with subtype 4k, 1 with subtype 4n, 8 with subtype 4r, and 3 with subtype 4t. Group B comprised 2 patients with subtype 4h, 1 with subtype 4l, and 1 with subtype 4k.

2 on the fully automated CAP-CTM 96 docked platform has potential for HIV VL monitoring in high-throughput settings. Although not investigated in this study, the CAP-CTM HIV-1 v2.0 also has the capability of detecting HIV group O per the manufacturer's instructions but requires further field evaluation for HIV-1 subtypes other than subtype C. The six lines shown represent the six replicates. The SD and %CV on the log values are represented for each dilution as well as the %CV for the absolute VL values. The equation of the line is also represented on the plot. The symbol keys indicate the assays for each plotted point. This publication was made possible by the generous support of the American people through the U.S. Agency for International Development.Lancet i: 307 -310. OpenUrl CrossRef PubMed Web of Science 3. ? Brambilla, D., S. Granger, and J. Bremer. Nucleic Acids Res. 35: e101. OpenUrl CrossRef PubMed 5. ? Kwok, S., and J. J. Sninsky. American Society for Microbiology, Washington, DC. 6. ? Oliver, A. R., S. F. Pereira, and D. A. Clark. Virus Genes 26: 151 -163. OpenUrl CrossRef PubMed Web of Science 8. ? Roche Molecular Systems. Cytometry 54B: 46 -53. OpenUrl PubMed NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. We do not retain these email addresses. NW Washington, DC 20036 Phone: (202) 737-3600. This article has been cited by other articles in PMC. Abstract Accurate hepatitis C virus (HCV) RNA quantification is mandatory for the management of chronic hepatitis C therapy. INTRODUCTION Accurate hepatitis C virus (HCV) RNA quantification is mandatory for the management of chronic hepatitis C therapy. Futility rules have been established in order to prevent unnecessary exposure to the protease inhibitor and to avoid adverse events, the emergence of viral resistance, and useless costs.

Since accurate quantification regardless of the HCV genotype is required in clinical practice, the manufacturer developed a new version (v2.0) of its TaqMan assay. The third-generation bDNA assay can be used as a reference method because of its accuracy and the lack of influence of the HCV genotype on quantification, due to the use of a large number of hybridization probes without the need for prior PCR amplification. This is not surprising, because different assays often have slight differences in their calibration in spite of the use of the World Health Organization standard, with no impact in clinical practice. European Association for the Study of the LiverGhany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB.Hepatology. Chevaliez S, Rodriguez C, Pawlotsky JM.Gastroenterology. Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R.Fried MW, Hadziyannis SJ, Shiffman ML, Messinger D, Zeuzem S.Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S.Poordad F, McCone J, Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP.Jacobson IM, Bartels DJ, Gritz L, Kieffer TL, De Meyer S, Tomaka F, Bengtsson L, Luo D, Adiwijaya BS, Kauffman RS, Picchio G, Adda N.Jacobson IM, Marcellin P, Zeuzem S, Sulkowski MS, Esteban R, Poordad F, Bruno S, Burroughs MH, Pedicone LD, Boparai N, Deng W, Dinubile MJ, Gottesdiener KM, Brass CA, Albrecht JK, Bronowicki JP.Sarrazin C, Hezode C, Zeuzem S, Pawlotsky JM.Akhavan S, Ronsin C, Laperche S, Thibault V.Hepatology. Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM.Hepatology. Chevaliez S, Bouvier-Alias M, Castera L, Pawlotsky JM.

The Cobas TaqMan 96 analyzer was used for automated real-time PCR amplification and detection of PCR products according to the manufacturer's instructions. Statistical analysis. Relationships between quantitative variables were studied by means of regression analysis. For this, we used Deming regression, a statistical method for comparing non-gold-standard laboratory methods that takes measurement errors for both methods into account. For better visualization of differences between the quantification assays, we also used the Bland-Altman plot method, in which the differences between the two techniques are plotted against the averages of the two techniques. P values of RESULTS HCV RNA quantification accuracy and influence of the HCV subtype. This figure includes Deming regressions and Bland-Altman representations for pairwise comparisons of the assays. In the Deming regression figures, the dashed line is the identity line; the black line surrounded by two dashed lines shows the Deming fit and 95% confidence interval, respectively. Only subtypes with more than five samples are represented. The midline and lower and upper edges of the boxes represent the median value, 25th percentile, and 75th percentile, respectively. The lower and upper error bars represent the 10th and 90th percentiles, respectively. The dots represent values that are below the 10th percentile or above the 90th percentile. None of the 118 clinical specimens harbored a G-to-A substitution at position 145, whereas 13 harbored an A-to-T substitution at position 165 ( Table 1 ). Among these techniques, the Cobas TaqMan assays are the most widely used worldwide. Even more challenging was the identification of clinical samples in which the first-generation Cobas TaqMan assays did not detect HCV RNA, whereas high virus titers were found with other assays, including real-time PCR assays ( 11, 13 ).

Republique Centrafricaine Prevalence de l’Infection VIH et Facteurs. Associes en Republique Centrafricaine en 2010. Institut Centrafricain des Statistiques et des Etudes Economiques et Sociales, 2012. Elimination of mother-to-child transmission of HIV and syphilis: A dual approach in the African Region to improve quality of antenatal care and integrated disease control. Int J Gynaecol Obstet 2015; 130(Suppl. 1): S27-31. Biometrics 1977; 33(1): 159-74. Educ Psychol Meas 1960; 20: 37-46. HIV-1 load comparison using four commercial real-time assays. J Clin Microbiol 2011; 49(1): 292-7. J Clini Virol 2002; 25(Suppl 3): S103-7. J Clin Microbiol 2007; 45(10): 3436-8. Currently Dr. Bukrinsky is Professor of Microbiology, Immunology and Tropical Medicine in the George Washington University School of Medicine and Health Sciences. He has published more than 150 scientific publications and is a named inventor of 12 issued U.S patents. Dr. Bukrinsky is currently the Editor-in-Chief of this journal (Open AIDS Journal), published by Bentham Science Publishers. Department of Microbiology and Tropical Medicine, The George Washington University, Washington, USA View Editorial Board Bentham Open ensures speedy peer review process and accepted papers are published within 2 weeks of final acceptance. We believe that a dedicated and committed team of editors and reviewers make it possible to ensure the quality of the research papers. The overall standing of a journal is in a way, reflective of the quality of its Editor(s) and Editorial Board and its members. Relevant and timely articles are made available in a fraction of the time taken by more conventional publishers. In the latter case, pleaseHow are we doing. Europe PMC is part of the ELIXIR infrastructureEurope PMC is a service of theIt includes content provided to the. Paralelamente, la Microbiologia y la Infectologia Clinicas han experimentado un gran desarrollo como respuesta al reto planteado por la actual patologia infecciosa.

Enfermedades Infecciosas y Microbiologia Clinica es la Publicacion Oficial de la Sociedad Espanola SEIMC. Cumple con la garantia cientifica de esta Sociedad, la doble funcion de difundir trabajos de investigacion, tanto clinicos como microbiologicos, referidos a la patologia infecciosa, y contribuye a la formacion continuada de los interesados en aquella patologia mediante articulos orientados a ese fin y elaborados por autores de la mayor calificacion invitados por la revista. SJR usa un algoritmo similar al page rank de Google; es una medida cuantitativa y cualitativa al impacto de una publicacion. Certain HPV genotypes, the so-called high-risk genotypes (HR), have an established role in cervical carcinogenesis. Detection of HR genotypes in cervical samples is an important measure for preventing cancer of the cervix and, together with Papanicolaou smears, is the cornerstone of cervical cancer screening. Currently, two useful assays are available for detecting HPV in cervical samples, hybrid capture (HC) and polymerase chain reaction (PCR). PCR has several advantages over HC, but also some problems; mainly, the test is time-consuming, experience in molecular assays is needed, and cross-contamination is common. A validated, reliable, fast, easy to perform, semior fully-automated assay would be desirable for HPV detection and genotyping, particularly in laboratories that handle a large number of samples. Genotyping methods are important for improving our understanding of the progression of infection to cervical cancer, since individual risk stratification, the prevalence and persistence of infection, and the onset of new infections can be determined by genotyping 1. The development of HPV vaccine also depends on typing 2. Stevens et al recently described an automated extraction system, Roche MagNA Pure LC, as an alternative method for specimen processing before using the linear array HPV test (LA) for detecting and genotyping HPV 3.

Hepatology. Chevaliez S, Fix J, Soulier A, Pawlotsky JM.Germer JJ, Bommersbach CE, Schmidt DM, Bendel JL, Yao JD.Kamal SM, Nasser IA.Hepatology Bronowicki JP, Ouzan D, Asselah T, Desmorat H, Zarski JP, Foucher J, Bourliere M, Renou C, Tran A, Melin P, Hezode C, Chevalier M, Bouvier-Alias M, Chevaliez S, Montestruc F, Lonjon-Domanec I, Pawlotsky JM.Gastroenterology. Soler M, Pellerin M, Malnou CE, Dhumeaux D, Kean KM, Pawlotsky JM. This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0)Indeed, in sub-Saharan Africa, non-B subtypes of HIV-1 are predominant.In contrast, the upgraded version 2.0 showed 100%-sensitivity, 100%-specificity and perfect agreement (.The assay includes an internal control consisting of armored RNA containing binding sites identical to the HIV-1 target sequence but a unique probe-binding region. The internal control is added to each specimen prior to extraction at a defined concentration. It controls for both the extraction and amplification processes, including variable input and suboptimal amplification through inhibition. Fluorescence readings for the internal control need to conform to pre-set criteria for the specimen result to be regarded as valid. In addition to the internal control, the assay includes external controls in each run, namely a low positive control (to detect inadequate sensitivity) and a negative control (to detect contamination).Informed written consent was obtained from all mothers for themselves and on behalf of their respective children participating in the study. After air-drying for 3 hours at room temperature, the Whatman filter papers were stored in plastic bags with silica desiccants and humidity indicator cards. Two DPS cards were prepared for each patient. The test was performed according to the manufacturer's instructions.

Specificity (Sp) was calculated as the number of real negatives divided by the sum of real negatives plus false positives.Dr MA Jenabian is the holder of the Canada Research Chair in Immuno-virology Tier 2. WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection Recommendations for a public health approach 2013. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med 2008; 359(21): 2233-44. Early detection of HIV infection in infants and children. Guidance note on the selection of technology for the early diagnosis of HIV in infants and children 2007. Clin Microbiol Infect 2010; 16(10): 1525-31. Impact of human immunodeficiency virus type 1 (HIV-1) genetic diversity on performance of four commercial viral load assays: LCx HIV RNA Quantitative, AMPLICOR HIV-1 MONITOR v1.5, VERSANT HIV-1 RNA 3.0, and NucliSens HIV-1 QT. J Clin Microbiol 2005; 43(8): 3860-8. Efficiencies of four versions of the AMPLICOR HIV-1 MONITOR test for quantification of different subtypes of human immunodeficiency virus type 1. J Clin Microbiol 1999; 37(1): 110-6. HIV-1 Genetic variability and clinical implications. ISRN Microbiol 2013; 2013: 481314. Trends Mol Med 2012; 18(3): 182-92. J Clin Virol 2012; 53(2): 106-9. J Clin Microbiol 2010; 48(4): 1413-6. J Virol Methods 2015; 229: 12-5. Impact of HIV-1 genetic diversity on plasma HIV-1 RNA Quantification: usefulness of the Agence Nationale de Recherches sur le SIDA second-generation long terminal repeat-based real-time reverse transcriptase polymerase chain reaction test. J Acquir Immune Defic Syndr 2007; 45(4): 380-8. Usefulness of a genotypic resistance test using dried blood spot specimens in African HIV-infected children with virological failure according to the 2010-revised WHO criteria. Arch Virol 2011; 156(9): 1603-6. Quantitation of HIV-1 RNA in dried blood spots by the real-time NucliSENS EasyQ HIV-1 assay in Senegal. J Virol Methods 2008; 148(1-2): 291-5.

The authors recommend the use and validation of automated nucleic acid purification platforms to simplify the assay's extraction step. The Cobas AmpliPrep (CA) (Roche Diagnostics, S.L., Barcelona, Spain) instrument is used for quantification of hepatitis B, hepatitis C, HIV, CMV and other viruses in clinical samples in many clinical microbiology laboratories. Our study sought to compare automated HPV nucleic acid extraction by the CA with the manual AmpliLute (MA) (Roche Diagnostics, S.L., Barcelona, Spain) protocol, a commercially available liquid media extraction kit. Then, all samples were analyzed by LA assay for HPV genotyping by automated system using the recommended protocol, except that a 100-?l aliquot of the CA denatured amplicons was used. The staff carrying out the study had not been specifically trained in molecular techniques. One positive and one negative control were processed with each run of up to 22 specimens. The internal control included in the kit was ?-globin. An additional primer pair targets the human ?-globin gene, which was isolated concurrently. All 100 samples analyzed generated positive high and low ?-globin results (two visible bands for each strip) using the two protocols, thus demonstrating adequate specimen integrity, DNA extraction, and amplification 4. An alternative test, Hybrid Capture II (HC2) (Digene, Gaithersburg, USA), was used to analyze discrepant samples. Four HR-HPV were negative and three positive, one of them with low signal intensity. Table 1 lists the results of these 7 discrepant samples with all the methods used (MA, CA and HC2), as well as the cytology data 5. Some cross-contamination cannot be ruled out in the MA results. In fact, cross-contamination was not unexpected considering the manner in which the manual method is performed. Our data show that for detecting HR-HPV in cytology specimens with borderline changes, MA detected slightly more cases and reached a higher analytic sensitivity than CA.

Both tests performed similarly with respect to identification of HPV in high-grade disease. Table 1. High-risk HPV detection by AmpliLute (MA), COBAS AmpliPrep (CA), Hybrid Capture II (HC2) and cytology 6 in discordant samples Pacient Although PCR-based assays have not yet been approved by the U.S. Food and Drug Administration for clinical use, they provide a rapid means of HPV detection and genotyping in clinical practice. The LA HPV genotyping test is a standardized, consistent, rapid method for detecting and typing up to 37 HPV mucosal genotypes 6. Nevertheless, MA can be time-consuming and labor-intensive in clinical settings where many cervical samples are processed. In this context, and based on our data, we propose to replace the manual extraction step by the automated method evaluated in our study. This method provides several advantages and, in agreement with Stevens' results 3, the two extraction methods demonstrated only slight differences in the outcome, although a small number of samples were analyzed and larger studies would be desirable. The use of an automated system for DNA isolation would greatly improve simplicity, time and labor efficiency, and reduce potential sample cross-contaminations, thus allowing many cervical samples to be processed simultaneously for cervical cancer screening. J Clin Virol, 32 (2005), pp.Si continua navegando, consideramos que acepta su uso. Puede cambiar la configuracion u obtener mas informacion aqui. Continuing navigation will be considered as acceptance of this use. You can change the settings or obtain more information by clicking here. Se continuar a navegar, consideramos que aceita o seu uso. Voce pode alterar a configuracao ou obter mais informacoes aqui. Google Scholar 3. Armstrong GI, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Hepatitis C virus and liver transplantation.

Treatment of acute hepatitis C with interferon alfa-2b. Lagging M, Langeland N, Pedersen C, Farkkila M, Buhl MR, Morch K, Dhillon AP, Alsio A, Hellstrand K, Westin J, Christensen P, Leutscher P, Norkrans G for the NORDynamIC Study Group. Poordad F, McCone Jr J, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki J-P. Boceprevir for untreated chronic HCV genotype 1 infection. However, discrepancies and discordance between differentNigeria.Among the 81 detectable samples by both assays 4 samples (4.9%) had a log10. Bland and Altman’sDiscrepancies of clinicalThe implications of the inability of thePeriodic evaluation of platforms to detect new circulating HIV subtypes within eachKeywords: Improved performance, HIV-1 RNA, quantification, viral load. However, discrepancies and discordance between differentNigeria.Among the 81 detectable samples by both assays 4 samples (4.9%) had a log10. Bland and Altman’sDiscrepancies of clinicalThe implications of the inability of thePeriodic evaluation of platforms to detect new circulating HIV subtypes within eachAn HIV cure, therefore, cannot be achieved without the effective targeting of the virus in the CNS, for which in depthNested RT-PCR was used to amplify HIV gag and pol genes followed by sequencing.However, strains identified inUrgent prevention and behavior intervention in the population will beHIV namely GP120 envelope protein, reverse transcriptase, protease, integrase and ribonulcease. InTrajectories were recorded up to 20 ns simulation time in Desmond moduleHowever, the fluctuation of Chebulic acid with respect to integrase and ribonuclease. PLOS ONE promises fair, rigorous peer review,To increase access to viral load testing, alternative sample types like dried blood spots (DBS), which overcome the logistic barriers associated with plasma separation and cold chain shipment need to be considered and evaluated.

The work is made available under the Creative Commons CC0 public domain dedication. Data Availability: All relevant data are within the paper. Funding: This research has been supported through a CDC Cooperative Agreement with KEMRI. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. Among the obstacles are stringent costs associated with laboratory infrastructure, shipping of specimens to the few reference laboratories with capacity for VL testing, and frequent delays in receipt of results from such laboratories. The use of plasma, currently used for VL testing in RLS, is hampered by the need of preparation from whole blood specimens, storage requirements, and cold-chain transportation from usually remote areas to the centralized testing facilities. Therefore, there is need for a more feasible approach, such as the use of alternative specimen types, to help reduce costs and increase access to VL testing. Despite these advantages, DFS have still not been widely adopted into routine VL testing suggesting the need for more data to guide implementation. The secondary objective was to further assess the limit of detection for DBS using the Abbott assay. All study participants provided written informed consent for study participation. Intravenous whole blood specimens were collected in ethylenediamine tetra acetic acid (EDTA) anticoagulant tubes. For each whole blood and plasma specimen, two Whatman 903 cards were prepared, one for DBS and one for DPS, by spotting 75?L of whole blood and plasma respectively on each of the 5 spots, following manufacturers’ recommendations. The DBS and DPS were air dried at ambient temperature in laminar flow overnight and then packed with desiccant and humidity indicator cards.Briefly, 1000 ?

L of plasma specimens were aliquoted into the respective specimen tubes after a brief vortexing obtain a uniform mix.For DFS RNA extraction was done following the manufacturer’s procedure, briefly described as follows; for each specimen, two half-inch disks (two spots) were obtained from each card and placed in respectively labeled 15 mL propylene tube. Then, 1.7 mL of bulk m-lysis reagent, provided with the Abbott sample preparation assay, was added into each tube and incubated for 15 minutes, with intermittent mixing at room temperature, to lyse. The lysates were transferred to respective m2000sp reaction vessels.To analyze reproducibility for the Abbott assay using DBS and DPS, the concordance correlation coefficient and Bland-Altman were utilized. We used probit analysis to determine the limit of detection of the Abbott assay using DBS, and the receiver-operating curve and likelihood ratios were used to estimate the various clinical relevant cut-offs for treatment failure. All statistical analyses were conducted using SAS, version 9.2 (SAS Inc., Cary, North Carolina, USA). DBS VL; b ) Abbott plasma vs. DBS VL. DPS VL; b ) Abbott plasma vs. DPS VL. The difference between the references Run 1 and the comparisons Run 2 were plotted against the average of the reference group. Following the recent WHO guidelines, countries in sub-Saharan Africa have adopted routine VL monitoring. However, implementation is hampered by, among others, suitable specimen type for patients from remote areas. The performance of DFS is an alternative that could overcome the logistical constraints associated with plasma collection and shipment need to be assessed. This could further be the reason for the slightly lower specificity for the Abbott assay as it further fails to discriminate cellular RNA from cell-free RNA. These findings continue to highlight the need for assay-specific recommendations to guide DBS VL testing.